On December 11, 2023, the Government issued Decree No 88/2023/ND-CP (“Decree 88”), amending and supplementing provisions of Decree No 54/2017/ND-CP (“Decree 54”) and Decree No 155/2018/ND-CP. Decree 88 introduces several new regulations concerning the export and import of pharmaceuticals, raw materials for pharmaceutical production, and drug pricing management. The specific provisions are outlined as follows:
1. Clarification on import cases of pharmaceutical raw materials
According to the previous regulations in Decree 54, imported pharmaceutical raw materials included:(i) Pharmaceutical raw materials that have been registered for circulation in Vietnam; and
(ii) Pharmaceutical raw materials that are active ingredients, excipients, and semi-finished medicinal products excluding semi-finished herbal medicines for manufacturing medicinal products according to the drug registration dossier that has been granted a Certificate of Drug Registration in Vietnam by the Minister of Health.
Decree 88 clarifies case (ii) pharmaceutical raw materials used to manufacture drugs according to the registered dossier that has a Certificate of Drug Circulation in Vietnam, include not only active ingredients, excipients, and semi-finished medicinal products but also capsules shells and semi-finished herbal medicines.
In addition, Decree 88 clarifies that these types of pharmaceutical raw materials are not yet registered for circulation permit for drug manufacturing according to the drug registration dossier.
2. Supplementing cases of exclusion from registration of herbal medicines, excipients, and capsules shells
Decree 88 supplements the following cases that are not excluded from the registration of herbal medicines, excipients, and capsules:
- Semi-finished herbal medicines for manufacturing medicinal products according to the drug registration dossier that has been granted a Certificate of Drug Registration in Vietnam;
- Semi-finished products for testing, research, or manufacturing drugs for export;
- Excipients used for testing, research, or manufacturing drugs for export;
- Capsules shells used for testing, research, or manufacturing drugs for export.
3. Changes in assessing compliance with Good Manufacturing Practices for foreign pharmaceutical manufacturing facilities and pharmaceutical raw material producers registered for circulation in Vietnam
- Supplementing cases requiring on-site inspections for assessment: for pharmaceutical manufacturing facilities and pharmaceutical raw material producers in exporting countrieswhere Good Manufacturing Practices standards and principles are not applicable as prescribed, the dossier assessment will be conducted as an inspection at the manufacturing facility.
- Supplementing documents to assess the facility’s compliance with Good Manufacturing Practices: In case the principles and standards of Good Manufacturing Practices for pharmaceuticals and pharmaceutical raw materials are not covered by the principles and standards promulgated or announced for application by the Minister of Health (Principles and Standards), the Advisory Council issuing the Certificate of Drug Registration and Pharmaceutical Raw Materials will assess the suitability of the exporting country’s principles and standards with the Principles and Standards. After obtaining the appropriate assessment results, the Minister of Health will issue a decision recognizing the suitability of the exporting country’s Good Manufacturing Practice as a basis for assessing the manufacturing facility.
4. Supplementing regulations on post-inspection pice review of declared and re-declared drugs
a. Contents of post-inspection price review for declared and re-declared drugs:
- Information about the drug in the price declaration dossier aligns with the information of the drug according to the Decision granting a Certificate of Drug Registration or a License to import drugs;
- The declared and re-declared drug prices align with the market price level of similar drug products (if any).
b. If necessary, based on the above contents of the post-declaration price review, the state management agency of drug pricing will seek the opinions from relevant competent agencies to conduct a post-inspection price review for declared and re-declared drugs.
Decree 88 takes effect from the dat
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